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NDC 53002-1570-03 Isosorbide Mononitrate 30 mg/1 Details
Isosorbide Mononitrate 30 mg/1
Isosorbide Mononitrate is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is ISOSORBIDE MONONITRATE.
MedlinePlus Drug Summary
Isosorbide immediate-release tablets are used for the management of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Isosorbide extended-release (long-acting) tablets and extended-release capsules are used for the management of chest pain in people who have coronary artery disease. Isosorbide can only be used to prevent angina; it cannot be used to treat an episode of angina once it has begun. Isosorbide is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.
Related Packages: 53002-1570-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Isosorbide
Product Information
| NDC | 53002-1570 |
|---|---|
| Product ID | 53002-1570_71c6d4fe-5ef8-4b69-935b-ca3398cde54b |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Isosorbide Mononitrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Isosorbide Mononitrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/1 |
| Substance Name | ISOSORBIDE MONONITRATE |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075522 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1570-03 (53002157003)
| NDC Package Code | 53002-1570-3 |
|---|---|
| Billing NDC | 53002157003 |
| Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-1570-3) |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |